Corrective/Preventive Action response time - best practices?

[mdoody]

This is my first post to the Cove. If this question has been asked before, please bear with me. In the company that I work for, a Corrective Action was issued by an internal auditor in December of 03 for a company Procedure that was not being followed. The CAR was responded to in Feb. 04 that corrective action would be implemented in March 04. For various reasons (resources, commitment) the corrective action has not been implemented as of this date!
I have 2 questions: 1) What do Registrars consider a reasonable time frame for CAR implementation? 2) What are the best practices (time-wise) for CAR implementation?

[Bill Pflanz]

In Reply to Parent Post by mdoody

This is my first post to the Cove. If this question has been asked before, please bear with me.

I see you registered last year but welcome to the Cove as a poster.

In Reply to Parent Post by mdoody

1) What do Registrars consider a reasonable time frame for CAR implementation? 2) What are the best practices (time-wise) for CAR implementation?

A reasonable time plan is determined by the type of problem, how much time is needed to evaluate causes and solutions and how much time to implement. You original corrective action plan was probably acceptable but it is 8 months later and it was never implemented. If anything, the registrar would write a nonconformance for the lack of completion of the CAR. If you had valid reasons to delay the implementation than the change in the CAR plan should be documented and approved by management. Lack of resources and commitment would probably not be accepted as a valid reason since management has the responsibility to provide both.

Best practices would probably include a management review of the problem and a determination of what it would take to correct it. If the problem required a shutdown, captial expenditures, different supplier etc. than the time could be months. If it is an easy fix, less than a month would be appropriate. I would think your auditor would want to see all CARs closed out by the next scheduled audit unless there are valid special reasons such as described above.

Bill Pflanz

[michelle8075]

We just used the time frame set out by our registrar and implmented their requirments into out entire corrective/preventive action and intenal audit procedures. The practice that we empoly at my company is that the Corrective Action response is due within 15 days of that manager receiving the nonconformance. Then, the manager is responsible for implmentation of thier corrective action response 30 days after the corrective action response was received. Effectivness audit takes place 30-60 days after implmentation of the corrective action.

I had a very similar problem in my organization where I don't receive the corrective action responses, corrective action implementation or evidence of effectivness in a timely manner. An 3rd party auditor can site you for "Lack of Management Committment" if this becomes an ongoing problem.

[Carl Keller]

We use a mechanism to "escalate" the lack of response.


It goes something like:

Past due elevate to department manager
30 days past due elevate to department director
60 days past due elevate to company VP

Etc.

Carl-

[Bill Pflanz]

Michelle's time frame seems reasonable. One thing that should be noted. If you add the time frames into your audit procedures as specifically as Michelle has then you will be required to meet those standards. You may want to include what the process is to extend the time line when it is not practical to meet those standards. This addition must be done carefully since there is always someone who tries to circumvent the process by always asking for an extension.

Bill Pflanz

[Wes Bucey]

I like Carl's policy of escalating the issue if no progress appears to be forthcoming.

My policy has always been to "negotiate" a preliminary time frame in which the "owner" of the CAR has to respond with a definite time frame and plan for completion. (This meant every CAR could have a different time frame, depending on the nature of the nonconformity.) We put it into a tickler file and review the issue if it has not been resolved within the agreed time frame. In most of my employment, I have been the court of last resort, so I had no process for escalating the issue, but it certainly makes sense to me.

In practical terms, if I didn't get a response with a definite time frame within the preliminary due date, "review the issue" meant I went and stood over the person until I got the new date AND a plan for meeting that date or until the person packed and left the premises. CARs represent money and the life of the organization. I didn't request them willy nilly, but when I did, they were as serious as a heart attack. I absolutely did not allow ignoring a CAR. I did allow "postponing" with adequate reason and a plan for completion.
If I had a CAR unresolved for 4 weeks, we would have shut down the entire operation until we resolved it or found a reason to drop the issue in favor of asking to be relieved of our contract with the customer because we were unable to solve the problem and still make money. If anything had gone on for eight months, I would have been fired by the Board of Directors.

[Sidney Vianna]

In Reply to Parent Post by mdoody

This is my first post to the Cove. If this question has been asked before, please bear with me. In the company that I work for, a Corrective Action was issued by an internal auditor in December of 03 for a company Procedure that was not being followed. The CAR was responded to in Feb. 04 that corrective action would be implemented in March 04. For various reasons (resources, commitment) the corrective action has not been implemented as of this date!
I have 2 questions: 1) What do Registrars consider a reasonable time frame for CAR implementation? 2) What are the best practices (time-wise) for CAR implementation?

You have got lots of sound advice already. Registrars should not have a preconceived notion of timeframes because the severity of the issue will impact the organization's ability to resolve it. However, delinquent corrective action implementation is an endemic problem that affects many, many organizations.

I would just like to point out the two primary ISO 9001:2000 requirements that address this issue. On
5.6.2 Review input
The input to management review shall include information on
a) results of audits, b) customer feedback, c) process performance and product conformity, d) status of preventive and corrective actions, e) follow-up actions from previous management reviews, f) changes that could affect the quality management system, and g) recommendations for improvement.

and on 8.2.2 for CAR's triggered from the internal audit process, which, obviously, is not the only source for internal CAR's

8.2.2 Internal audit

The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2).

Sure, we can debate what is "undue delay" or timely. But, like Wes mentioned, without sound justification for delay of the CA implementation, management should be questionning really hard the seriousness of the people working there.

[michelle8075]

In Reply to Parent Post by Bill Pflanz

Michelle's time frame seems reasonable. One thing that should be noted. If you add the time frames into your audit procedures as specifically as Michelle has then you will be required to meet those standards. You may want to include what the process is to extend the time line when it is not practical to meet those standards. This addition must be done carefully since there is always someone who tries to circumvent the process by always asking for an extension.

Bill Pflanz

Bill, you are right, and I forgot to leave that part out. We do say "approximatly" 15 days (approimatly being a Quality "bad word", but we haven't had an auditor who had a problem with that yet). We also have in our system that if it is not answered in approx. 15 days, we send a reminder out to that manager (which they can send us an e-mail to extend the due dates and list the reasons), QA then reviews and approved/denies the request for an extension (this way it is in writing!). Then when we get no response, it escaltes to our Quality Steering Committee, etc.